Pharmaceutical Development Laboratory Project Manager (Formulation expert) - Mendrisio site (Ticino) — Sintetica SA
CHF 72'000 - 97'000
Sintetica SA · Mendrisio (TI)
- Location
- Mendrisio
- Contract
- other
- Posted
- —
SalaryCHF 72'000 - 97'000
Role overview
Pharmaceutical Development Laboratory Project Manager (Formulation expert)
Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI).
We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them.
- Pharmaceutical Development Laboratory Project Manager (Formulation expert)
- Mendrisio site (Ticino) — Sintetica SA, Mendrisio (TI).
- Key responsibilities Coordinate and execute the activities related to the assigned formulation development projects: Define qualitative and quantitative composition of formulations to ensure stability, compatibility, and bioavailability.
- Develop and optimize sterile injectable formulations (large and small volume parenteral, ophthalmic gels, suspensions, emulsions, lyophilized products) applying QbD principles and Design of Experiments (DoE) studies.
- and skills Master’s degree or PhD in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
- At least 10 years of post-degree work experience, including at least 5 years in Pharma R&D context.
Main responsibilities
- Key responsibilities Coordinate and execute the activities related to the assigned formulation development projects: Define qualitative and quantitative composition of formulations to ensure stability, compatibility, and bioavailability.
- Develop and optimize sterile injectable formulations (large and small volume parenteral, ophthalmic gels, suspensions, emulsions, lyophilized products) applying QbD principles and Design of Experiments (DoE) studies.
- Design and execute formulation trials, dissolution studies (including pilot-scale dissolutor testing), and data-driven optimization strategies.
- Evaluate extractables and leachable risk in collaboration with analytical team.
- Evaluate nitrosamines risk in collaboration with analytical team.
- Support aseptic processing or terminal sterilization strategy selection.
- Support scale-up activities and technology transfer to manufacturing.
- Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control and Regulatory Affairs.
- Improve galenical development and formulations selection by attending courses, seminars and meetings.
Key requirements
- and skills Master’s degree or PhD in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
- At least 10 years of post-degree work experience, including at least 5 years in Pharma R&D context.
- Familiarity with both small and macro-molecules API.
- Demonstrated expertise in injectable and/or ophthalmic formulation development.
- Proven hands-on expertise in aseptic processing, sterilization strategies, and lyophilization cycle development.
- Practical experience applying QbD principles and/or DoE in drug product development.
- Strong experience with late-stage development, scale-up and commercial product support.
- Familiarity with ICH/EU/US/Swiss laboratory guidelines related to the technical subjects.
- Excellent command of written and spoken English.
- Preference will be given to candidates based in Switzerland.
- We offer Fulltime permanent employment in a young working environment and positive culture.
- Sintetica promotes diversity and gender equality. Caricamento
What the company offers
- Mendrisio site (Ticino) Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.
Application process
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Contacts
- Inoltra ora la candidatura Compilare il form sottostante e inviare la candidatura. Nome Cognome Email
Additional details
- Qualifications and skills Master’s degree or PhD in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry).
- Sintetica promotes diversity and gender equality.
- Inoltra ora la candidatura Compilare il form sottostante e inviare la candidatura.
Notes and original content
- Caricamento